Hand Biomechanics Lab Inc
FDA inspection history in Sacramento, California, 2017 to 2022
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2017: one warning letter and one Form 483; 2022: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One warning letter and one Form 483, at Sacramento, California.
- 2022One close-out letter, at Sacramento, California.
Cited most
Across all Hand Biomechanics Lab observations on file
- 21 CFR 820.75(a)Process validation3
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
The complete Hand Biomechanics Lab file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Sacramento, California
One close-out letter, one warning letter and one Form 483 · 2017 to 2022 · 6 observations
Latest: Close-out, Sep 7, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-07 | Close-out Close-out letter | Sacramento, California | — | $99 |
| 2017-11-16 | Warning letter Warning letter | Sacramento, California | — | $99 |
| 2017-07-05 | 483 Form 483 | Sacramento, California | 6 | $99 |
Investigators on these documents
FEI number 2919128 · most recent document Sep 7, 2022
About Hand Biomechanics Lab Inc
How many FDA Form 483s has Hand Biomechanics Lab Inc received?
FDA Intel has 1 Form 483 on file for Hand Biomechanics Lab Inc; the most recent is dated Jul 5, 2017.
When was Hand Biomechanics Lab Inc last inspected by FDA?
The most recent FDA inspection document on file for Hand Biomechanics Lab Inc is a Form 483 dated Jul 5, 2017, for the site in Sacramento, California.
What did FDA cite at Hand Biomechanics Lab Inc?
The regulations cited most in the observations on file for Hand Biomechanics Lab Inc are 21 CFR 820.75(a) (Process validation), 3 times; 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Hand Biomechanics Lab Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hand Biomechanics Lab Inc; the most recent is dated Nov 16, 2017.